check_circleStudy Completed

Endometriosis

Bayer Identifier:

16997

ClinicalTrials.gov Identifier:

NCT02545452

EudraCT Number:

2014-005167-32

EU CT Number:

Not Available
Effect of concomitant use of an antimycotic, an antibiotic, a spermicide or tampons on pharmacokinetics of anastrozole and levonorgestrel released from intra-vaginal ring

Trial purpose

To investigate the pharmacokinetic effect of a vaginally
administered antimycotic (miconazole), antibiotic
(clindamycin), spermicide (nonoxynol-9) or the
concomitant use of tampons during the use of an intravaginal
ring releasing anastrozole and levonorgestrel

Key Participants Requirements

Sex

Female

Age

18 - 50 Years
  • - Healthy pre-menopausal female subject.
    - Age: 18 – 50 years (inclusive) at the first screening visit. For the subject > 45 years follicle stimulating hormone (FSH) will be investigated at the second screening visit to confirm the pre-menopausal status (FSH < 40 IU/L in serum).
    - Body mass index (BMI ) above or equal 18, and below or equal 30 kg / m² at the first screening visit.
    - Adequate venous access.
    - Ability to understand and follow study-related instructions
    - Agreement to use adequate non-hormonal contraception.
    - Confirmation of the subject’s health insurance coverage prior to the first screening examination/visit.

  • - Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal.
    - Thrombophlebitis, venous / arterial thromboembolic diseases (particularly deep vein thrombosis, pulmonary embolism, stroke, myocardial infarction).
    - Presence or history of prodromata of thrombosis (e.g. transient ischemic attack, angina pectoris).
    - Known hypersensitivity to the study medications (active substances or excipients of the preparations).
    - Regular intake of medication other than hormonal contraceptives.
    - Use of systemic or topical medication or substances which oppose the study objectives or which might influence them within 4 weeks before first administration of the study medication,
    - Smoking of more than 10 cigarettes daily; if the subject is a smoker: subject is older than 35 years
    - Suspicion of or known current drug, medicine or alcohol abuse (including anabolics, high-dose vitamins).
    - Abnormal cervical smear
    - Previous ectopic pregnancy.

Trial summary

Enrollment Goal
52
Trial Dates
September 2015 - July 2016
Phase
Phase 1
Could I Receive a placebo
No
Products
Anastrozole / Levonorgestrel (BAY98-7196)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Berlin, 13353, Germany

Primary Outcome

  • Average concentration (Cav) anastrozole after insertion of the intra-vaginal ring for all groups
    date_rangeTime Frame:
    202-226h
    enhanced_encryption
    Safety Issue:
    No
  • Average concentration (Cav) anastrozole after insertion of the intra-vaginal ring for all groups
    date_rangeTime Frame:
    226-298h
    enhanced_encryption
    Safety Issue:
    No
  • Average concentration (Cav) anastrozole after insertion of the intra-vaginal ring for all groups
    date_rangeTime Frame:
    226-384h
    enhanced_encryption
    Safety Issue:
    No
  • Average concentration (Cav) anastrozole after insertion of the intra-vaginal ring for Tampon group
    date_rangeTime Frame:
    466-490h
    enhanced_encryption
    Safety Issue:
    No
  • Average concentration (Cav) anastrozole after insertion of the intra-vaginal ring for Tampon group
    date_rangeTime Frame:
    490-562h
    enhanced_encryption
    Safety Issue:
    No
  • Average concentration (Cav) anastrozole after insertion of the intra-vaginal ring for Tampon group
    date_rangeTime Frame:
    490-648h
    enhanced_encryption
    Safety Issue:
    No
  • Average concentration (Cav) levonorgestrel after insertion of the intra-vaginal ring for all groups
    date_rangeTime Frame:
    202-226h
    enhanced_encryption
    Safety Issue:
    No
  • Average concentration (Cav) levonorgestrel after insertion of the intra-vaginal ring for all groups
    date_rangeTime Frame:
    226-298h
    enhanced_encryption
    Safety Issue:
    No
  • Average concentration (Cav) levonorgestrel after insertion of the intra-vaginal ring for all groups
    date_rangeTime Frame:
    226-384h
    enhanced_encryption
    Safety Issue:
    No
  • Average concentration (Cav) levonorgestrel after insertion of the intra-vaginal ring for Tampon group
    date_rangeTime Frame:
    466-490h
    enhanced_encryption
    Safety Issue:
    No
  • Average concentration (Cav) levonorgestrel after insertion of the intra-vaginal ring for Tampon group
    date_rangeTime Frame:
    490-562h
    enhanced_encryption
    Safety Issue:
    No
  • Average concentration (Cav) levonorgestrel after insertion of the intra-vaginal ring for Tampon group
    date_rangeTime Frame:
    490-648h
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Maximum observed plasma concentration before co-medication or tampons (Cmax)
    date_rangeTime Frame:
    490h
    enhanced_encryption
    Safety Issue:
    No
  • Time to reach maximum observed concentration before co-medication or tampons (tmax)
    date_rangeTime Frame:
    490h
    enhanced_encryption
    Safety Issue:
    No
  • Plasma concentration 28 days after intra-vaginal ring (IVR) insertion (Treatment group D, Day 29) (C(28d))
    date_rangeTime Frame:
    672h
    enhanced_encryption
    Safety Issue:
    No
  • Plasma concentration 35 days after IVR insertion (Treatment group D, Day 36)(C(35d))
    date_rangeTime Frame:
    840h
    enhanced_encryption
    Safety Issue:
    No
  • Average concentration in the extended wearing period (Treatment D, Days 29-36 using the same IVR)
    date_rangeTime Frame:
    672-840h
    enhanced_encryption
    Safety Issue:
    No
  • Terminal half-life associated with the terminal slope after removal of IVR (t1/2)
    date_rangeTime Frame:
    Up to 6 days after IVR removal
    enhanced_encryption
    Safety Issue:
    No
  • Number of participants with adverse events as a measure of safety and tolerability
    date_rangeTime Frame:
    Up to 14 days after IVR removal
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

A parallel group, randomized, open-label study to investigate the effect of the intravaginally administered antimycotic miconazole, antibiotic clindamycin, spermicide nonoxynol-9, or co-usage of tampons on 3 consecutive days on the pharmacokinetics of anastrozole and levonorgestrel released from an intra-vaginal ring in healthy young women
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Diagnostic
Allocation
Randomized
Blinding
Open Label
Assignment
Parallel Assignment
Trial Arms
4

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